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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K220893
Device Name Strados Remote Electronic Stethoscope Platform (RESP)
Applicant
Strados Labs, Inc.
1315 Walnut St., Suite 1101
Philadelphia,  PA  19107
Applicant Contact Nicholas Delmonico
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.2800
Classification Product Code
DSH  
Date Received03/28/2022
Decision Date 04/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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